Silodosin Recordati

Package leaflet: Information for the patient

Silodosin Recordati 8 mg hard capsules, 4 mg hard capsules

silodosin
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Silodosin Recordati is and what it is used for
2. What you need to know before taking Silodosin Recordati
3. How to take Silodosin Recordati
4. Possible side effects
5. How to store Silodosin Recordati
6. Contents of the pack and other information

1. What Silodosina Recordati is and what it is used for

What Silodosina Recordati is
Silodosina Recordati belongs to a group of medicines called alpha-1 adrenoceptor blockers.
Silodosina Recordati is selective for receptors located in the prostate, bladder, and urethra. By blocking these receptors, the medicine relaxes the smooth muscle in these tissues. This makes urination easier and relieves symptoms.

What Silodosina Recordati is used for
Silodosina Recordati is used in adult men for the treatment of urinary symptoms associated with benign enlargement of the prostate (benign prostatic hyperplasia), such as:

• difficulty starting to urinate,
• sensation of not having completely emptied the bladder,
• frequent need to urinate, including at night.

2. What you need to know before taking Silodosin Recordati

Do not take Silodosin Recordati
if you are allergic to silodosin or to any of the other ingredients of this medicine (listed in
section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Silodosin Recordati

• If you are scheduled for eye surgery due to clouding of the lens ( cataract surgery ), it is important that you immediately inform your ophthalmologist that you are currently taking or have previously taken Silodosin Recordati. This is because some patients treated with this type of medicine have experienced loss of iris muscle tone (the colored circular part of the eye) during such surgery. The ophthalmologist will take appropriate precautions regarding the medicines and surgical techniques to be used. Ask your doctor whether it is necessary to postpone or temporarily discontinue treatment with Silodosin Recordati prior to cataract surgery.
• If you have previously fainted or felt dizzy upon standing up suddenly, inform your doctor before taking Silodosin Recordati. Dizziness when standing up and, occasionally, fainting may occur while taking Silodosin Recordati, particularly at the beginning of treatment or if you are taking other medicines that lower blood pressure. If this happens, sit or lie down immediately until symptoms resolve and inform your doctor as soon as possible (see also section “Driving and use of machines”).
• If you have severe liver problems , do not take Silodosin Recordati, as the medicine has not been studied in patients with these conditions.
• If you have kidney problems , consult your doctor. If you have moderate kidney problems, your doctor will start treatment with Silodosin Recordati cautiously and possibly at a reduced dose (see section 3 “Dosage”). If you have severe kidney disease, you must not take Silodosin Recordati.
• Since benign enlargement of the prostate and prostate cancer may present with similar symptoms, your doctor will check whether you have prostate cancer before starting treatment with Silodosin Recordati. Silodosin Recordati is not a treatment for prostate cancer.
• Treatment with Silodosin Recordati may lead to abnormal ejaculation (reduced amount of semen released during sexual activity), which may temporarily impair male fertility. This effect disappears after discontinuation of treatment with Silodosin Recordati. Inform your doctor if you wish to have children.

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age, as there is no indication for this age group.
Other medicines and Silodosin Recordati
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
In particular, inform your doctor if you are taking:

• medicines that lower blood pressure (especially medicines called alpha-blockers such as prazosin or doxazosin), because there is a potential risk that the effect of these medicines may be increased during treatment with Silodosin Recordati.

• antifungal medicines (such as ketoconazole or itraconazole), medicines used to treat HIV/AIDS infection (such as ritonavir), or medicines used after organ transplantation to
  prevent organ rejection (such as cyclosporine), because these medicines may
  increase the concentration of Silodosin Recordati in the blood.

• medicines used to treat erectile dysfunction (such as sildenafil or tadalafil), because concomitant use with Silodosin Recordati may cause a slight reduction in blood pressure.

• medicines for epilepsy or rifampicin (a medicine used to treat tuberculosis), because the effect of Silodosin Recordati may be reduced.

Pregnancy and breastfeeding
Silodosin Recordati is not intended for use in women.
Fertility
Silodosin Recordati may reduce the amount of sperm and could therefore temporarily impair the ability to conceive. If you wish to have children, consult your doctor or pharmacist before taking this medicine.
Driving and use of machines
Do not drive and do not operate machinery if you feel faint, dizzy, or sleepy, or if you have blurred vision.
Silodosin Recordati contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is essentially
‘sodium-free’.

3. How to take Silodosina Recordati

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is one Silodosina Recordati 8 mg capsule daily, taken orally.
Take the capsule always with a meal, preferably at the same time each day. Do not crush or
chew the capsule; swallow it whole, preferably with a glass of water.
Patients with kidney problems
If you have moderate kidney problems, your doctor may prescribe a different dose. For these cases,
Silodosina Recordati 4 mg hard capsules are available.
If you take more Silodosina Recordati than you should
If you have taken more than one capsule, inform your doctor as soon as possible. If you feel dizzy or weak,
contact your doctor immediately.
If you forget to take Silodosina Recordati
If you forget to take a capsule, you may take it later the same day. If it is almost time for the next dose,
skip the missed dose. Do not take a double dose to make up for a forgotten capsule.
If you stop taking Silodosina Recordati
If you stop treatment, your symptoms may return.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you notice any of the following allergic reactions: swelling of the face or throat, difficulty breathing, feeling faint, skin itching or hives, as these may become severe.

The most common side effect is a reduction in the amount of semen released during sexual activity. This effect disappears after stopping treatment with Silodosina Recordati.
Inform your doctor if you wish to have children.

Dizziness, even when standing up, and occasionally fainting, may occur.
If you feel weak or dizzy, sit or lie down immediately until symptoms subside. If you experience dizziness upon standing or fainting, inform your doctor as soon as possible.

Silodosina Recordati may cause complications during cataract surgery (eye surgery performed to treat clouding of the lens; see section “Warnings and precautions”).
It is important that you inform your ophthalmologist immediately if you are currently taking or have previously taken Silodosina Recordati.

The possible side effects are listed below:

Very common side effects (may affect more than 1 in 10 people)

• Abnormal ejaculation (reduced or absent semen emission during sexual activity; see section “Warnings and precautions”)

Common side effects (may affect up to 1 in 10 people)

• Dizziness, even when standing up (also see above in this section)
• Runny or stuffy nose
• Diarrhoea

Uncommon side effects (may affect up to 1 in 100 people)

• Decreased sexual desire
• Nausea
• Dry mouth
• Difficulty achieving or maintaining an erection
• Increased heart rate
• Skin allergic reaction symptoms such as rash, itching, hives, and drug-induced skin eruption
• Abnormal liver function tests
• Low blood pressure

Rare side effects (may affect up to 1 in 1,000 people)

• Rapid or irregular heartbeat (called palpitations)
• Fainting/loss of consciousness

Very rare side effects (may affect up to 1 in 10,000 people)

• Other allergic reactions with swelling of the face or throat

Not known (frequency cannot be estimated from the available data)

• Intraoperative floppy iris syndrome during cataract surgery (also see above in this section)

If you think this medicine is affecting your sexual life, tell your doctor.
Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Silodosin Recordati

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after
Exp/EXP. The expiry date refers to the last day of that month.
Do not store above 30 °C.
Keep in the original packaging to protect the medicine from light and moisture.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Silodosin Recordati contains
Silodosin Recordati 8 mg
The active substance is silodosin. Each capsule contains 8 mg of silodosin.
The other components are pregelatinized maize starch, mannitol (E421), magnesium stearate, sodium lauryl sulfate, gelatin, and titanium dioxide (E171). Refer to section 2 “Silodosin Recordati contains sodium”.
Silodosin Recordati 4 mg
The active substance is silodosin. Each capsule contains 4 mg of silodosin.
The other components are pregelatinized maize starch, mannitol (E421), magnesium stearate, sodium lauryl sulfate, gelatin, titanium dioxide (E171), and yellow iron oxide (E172). Refer to section 2 “Silodosin Recordati contains sodium”.

Description of the appearance of Silodosin Recordati and contents of the pack
Silodosin Recordati 8 mg are white, opaque, hard gelatin capsules, size 0 (approximately 21.7 x 7.6 mm).
Silodosin Recordati 4 mg are yellow, opaque, hard gelatin capsules, size 3 (approximately 15.9 x 5.8 mm).
Silodosin Recordati is available in packs containing 10, 20, 30, 50, 90, or 100 capsules. Not all pack sizes may be marketed.

Marketing Authorization Holder
Recordati Ireland Ltd.
Raheens East
Ringaskiddy Co. Cork
Ireland

Manufacturer
Recordati Industria Chimica e Farmaceutica S.p.A.
Via Matteo Civitali 1
I-20148 Milan
Italy
Laboratoires Bouchara-Recordati
Parc Mécatronic
03410 Saint Victor
France

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Recordati Ireland Ltd. Recordati Ireland Ltd.
Tél/Tel: +353 21 4379400 Tel: +353 21 4379400

България Luxembourg/Luxemburg
Recordati Ireland Ltd. Recordati Ireland Ltd.
Тел.: +353 21 4379400 Tél/Tel: +353 21 4379400

Česká republika Magyarország
Herbacos Recordati s.r.o. Recordati Ireland Ltd.
Tel: +420 466 741 915 Tel: +353 21 4379400

Danmark Malta
Recordati Ireland Ltd. Recordati Ireland Ltd.
Tlf: +353 21 4379400 Tel: +353 21 4379400

Deutschland Nederland
Recordati Pharma GmbH Recordati Ireland Ltd.
Tel: +49 731 70470 Tel: +353 21 4379400

Eesti Norge
Recordati Ireland Ltd. Recordati Ireland Ltd.
Tel: +353 21 4379400 Tlf: +353 21 4379400

Ελλάδα Österreich
Recordati Hellas Pharmaceuticals A.E. Recordati Ireland Ltd.
Τηλ: +30 210-6773822 Tel: +353 21 4379400

España Polska
Casen Recordati, S.L. Recordati Polska sp. z o.o.
Tel: +34 91 659 15 50 Tel: +48 22 206 84 50

France Portugal
Laboratoires Bouchara-Recordati Jaba Recordati, S.A.
Tél: +33 1 45 19 10 00 Tel: +351 21 432 95 00

Hrvatska România
Recordati Ireland Ltd. Recordati România S.R.L.
Tel: +353 21 4379400 Tel: +40 21 667 17 41

Ireland Slovenija
Recordati Ireland Ltd. Recordati Ireland Ltd.
Tel: +353 21 4379400 Tel: +353 21 4379400

Ísland Slovenská republika
Recordati Ireland Ltd. Herbacos Recordati s.r.o.
Sími: +353 21 4379400 Tel: +420 466 741 915

Italia Suomi/Finland
Recordati Industria Chimica e Farmaceutica S.p.A. Recordati Ireland Ltd.
Tel: +39 02 487871 Puh/Tel: +353 21 4379400

Κύπρος Sverige
Recordati Ireland Ltd. Recordati Ireland Ltd.
Τηλ: +353 21 4379400 Tel: +353 21 4379400

Latvija United Kingdom (Northern Ireland)
Recordati Ireland Ltd. Recordati Ireland Ltd.
Tel: +353 21 4379400 Tel: +353 21 4379400

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu